Trial from ANZCTR


Trial ID ACTRN12607000423415
Trial Status: Registered
Date Submitted: 15/08/2007
Date Registered: 22/08/2007
Prospectively registered

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Public title Health Improvement and Prevention Study
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomized controlled trial of a general practice based intervention to prevent chronic vascular disease
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Secondary ID [1] 459 0
Nil
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UTN
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Trial acronym HIPS
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Health condition(s) or problem(s) studied:
Vascular disease,
Diabetes Mellitus,
Coronary Heart Disease,
Hypertension
Obesity
Stress
2260 0
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Condition category: Condition code:
Cardiovascular Hypertension
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2350 2350 0 0
Metabolic and Endocrine Diabetes
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2351 2351 0 0
Mental Health Studies of normal psychology, cognitive function and behaviour
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2352 2352 0 0

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Descriptions of intervention(s) / exposure This project will be conducted as a randomized controlled trial with randomisation at the level of practices. After baseline data collection from 32 practices and their staff, practices will be randomized into the intervention or the control group (16 in each group). The intervention will be undertaken by the researchers for the practices, and by clinician, for the patients (health check).


METHOD:
Six-month intervention driven by the Project officers from the Divisions will provide support to participating practices to implement the health check. The intervention will focus on :
1) Clinician awareness and use of motivational interviewing/stages of change to provide appropriate brief interventions during the health check
2) Clinical staff awareness of 5A’s and opportunities for intervention.
3) Patients requiring follow up with the GP are either recalled to the practice by a systematic method, or are provided with their next appointment at the time of consultation.
4) Regular and comprehensive assessment and monitoring is carried out;
5) A systematic approach to maintaining patient registers;
6) Comprehensive recording of SNAP (S= quit Smoking, N=better Nutrition, A=moderate Alcohol, P=more Physical activity) risk factors and interventions in a searchable electronic format;
7) Maintaining an up-to-date directory of linkages with health professionals or organisations for SNAP-related referrals, and a systematic approach for updating this;
8) A systematic approach to providing patient education and resources (paper or electronic);
9) Practice support by identification the potential for expansion of the roles and responsibilities of non-GP staff to support prevention and strategies to do this;
10) Practice support in billing systems which include the health check
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Intervention Code:
Prevention 1972 0
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Intervention Code:
Lifestyle 1973 0
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Intervention Code:
Behaviour 1974 0
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Comparator / control treatment Control group will commence intervention at the conclusion of the study. The facilitators for this will be based in the Divisions.
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Control group Active
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Primary Outcome: Primary Outcome 1: Change in Patient's absolute risk of cardiovascular disease. 3248 0
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Timepoint: baseline, 6 months, and 12 months 3248 0
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Primary Outcome: Primary Outcome 2: Change in single behavioural (Smoking, Diet, Physical Activity) and physiological risk factors (Blood pressure, Total Cholesterol) 3249 0
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Timepoint: baseline, 6 months, and 12 months 3249 0
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Primary Outcome: Primary Outcome 3: Change in Preventive Care received (assessment of behavioural risk factors, blood pressure, fasting lipids,fasting blood glucose) over previous 6 months 3250 0
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Timepoint: baseline, 6 months, and 12 months 3250 0
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Secondary Outcome: Secondary Outcome 1: Change in patient assessed access and patient centredness of primary care using General Practice Assessment Questionnaire (GPAQ) 5412 0
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Timepoint: baseline, 6 months, and 12 months 5412 0
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Secondary Outcome: Secondary Outcome 2: Change in capacity of general practices to provide preventive care (appointment systems, information systems, team roles) 5413 0
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Timepoint: 6 months, and 12 months 5413 0
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Secondary Outcome: Secondary Outcome 3: Change in patient psychosocial stress measured by the K10 questionnaire. 5414 0
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Timepoint: baseline, and 12 months 5414 0
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Key inclusion criteria General Practices will be eligible to participate if they use computer-based medical records, are not currently involved in other research, and are located in the participating Divisions of General Practice. Patients in participating practices will be eligible for inclusion in the study if they are aged 45-65 years and have History of Gestational Diabetes (GDM), “Pre diabetes” – impaired glucose tolerance or impaired fasting glycaemia, or elevated blood pressure (or on treatment for high blood pressure) or high cholesterol (or on treatment for cholesterol), Overweight (BMI >28 or waist circumference >102 in males and >88 in females), and current smoker.
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Minimum age 45 Years
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Maximum age 65 Years
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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria Patients are excluded if they (i) have current severe illness or personal circumstances which are of overriding concern (ii) are deceased (iii) are no longer a patient of the practice (iv) have diabetes or cardiovascular disease (v) are unlikely to be able to read and understand the information sheet and consent form
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) After baseline data collection on the practices and their staff, practices will be randomized into the intervention or the control group (cluster randomiization of practices to early or delayed intervention). A university of NSW staff member not linked to the study data collection will perform the randomisation. Project officers and staff collecting data will be blinded to randomisation.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Permuted block design will be used to randomise participating practices into intervention and control groups. Practices within each division of general practice will constitute one block. The aim is to recruit 4-8 practices within each participating division of general practice.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features N/A
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 24/09/2007
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 1280
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: Eastern Sydney: 2000, 2008, 2010, 2011, 2012, 2021, 2022, 2023, 2025, 2056, 2027, 2028, 2029, 2030 218 0
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Postcode: South Eastern Sydney: 2015, 2017, 2018, 2019, 2020, 2024, 2031, 2032, 2033, 2034, 2035, 2036, 2052 219 0
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Postcode: Central Sydney: 2001, 2006, 2007, 2008, 2009,2015, 2016, 2017, 2037, 2038, 2039, 2040, 2041, 2042,2043, 2044, 2045, 2046, 2047, 2048, 2049, 2050,2127, 2128, 2129, 2130, 2131, 2132,2133, 2134, 2135, 2136, 2137, 2138, 2139, 2140, 2203, 2204 220 0
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Postcode: Northern Rivers: 2463, 2464, 2465, 2466, 2469, 2470, 2471, 2472, 2473, 2474, 2475, 2476, 2477, 2478, 2479, 2480, 2481, 2482, 2483 221 0
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Postcode: Dubbo Plains: 2357, 2395, 2396, 2820, 2821, 2823, 2824, 2825, 2827, 2828, 2829, 2830, 2831, 2842, 2843, 2844, 2850, 2852, 2869 222 0
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Recruitment outside Australia

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Funding Source: Government body 2512 0
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Name: National Health and Medical Research Council (NHMRC) 2512 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
2512 0
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Country: Australia 2512 0
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Primary Sponsor University
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Name: University of New South Wales (UNSW)
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Address: School of Public Health and Community Medicine, UNSW
Sydney NSW 2052
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Country: Australia
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Secondary Sponsor: University 2278 0
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Name: University of Sydney 2278 0
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Address: Corrindah Court
PO Box 457
Broken Hill NSW 2880
2278 0
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Country: Australia 2278 0
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Other Collaborator: Other Collaborative groups 6 0
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Name: Central Sydney Division of General Practice 6 0
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Address: Level 1, 381 Liverpool Rd
Ashfield NSW 2131
6 0
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Country: Australia 6 0
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Other Collaborator: Other Collaborative groups 7 0
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Name: South East Sydney Division of General Practice 7 0
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Address: 6-8 Crewe Place
Roseberry NSW 2018
7 0
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Country: Australia 7 0
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Other Collaborator: Other Collaborative groups 8 0
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Name: Eastern Sydney Division of General Practice 8 0
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Address: Suit 103, Level1, 35 Spring St
Bondi Junction NSW 2022
8 0
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Country: Australia 8 0
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Other Collaborator: Other Collaborative groups 9 0
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Name: Dubbo/Plains Division of General Practice 9 0
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Address: PO Box 1834
Dubbo NSW 2830
9 0
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Country: Australia 9 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: UNSW Ethic Committee 4428 0
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Address: Ethic Committee
UNSW
Sydney NSW 2052
4428 0
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Country: Australia 4428 0
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Approval Date: 06/03/2007 4428 0
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Submitted Date: 4428 0
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HREC: HREC 07023 4428 0
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Brief summary This study aims to evaluate the impact of recalling patients to general practice for a visit to assess their risk of chronic disease and to help them to lower their risk by changes to smoking, diet, alcohol consumption and physical activity behaviours as well as pharmacological management of their blood pressure and cholesterol. Practices in the intervention group will receive training, practice visits, resources, and referral pathways to enable them to invite eligible patients to attend the practice for an assessment and management of their risk factors. This will include provision of education materials, support for behaviour change, referral to diet education and physical activity program and follow up.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Professor Mark Harris
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Address: School of Public Health and Community Medicine, UNSW Sydney NSW 2052
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Tel: +61 2 9385 2511
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Fax: +61 2 9313 6185
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Email: m.f.harris@unsw.edu.au
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Contact person for scientific queries
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Name: Professor Mark Harris
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Address: School of Public Health and Community Medicine, UNSW Sydney NSW 2052
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Contact person responsible for updating information
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Name: Dr Mahnaz Fanaian
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Address: School of Public Health and Community Medicine, (Building R1f – 22-32 King St Randwick) Sydney NSW 2052 Australia University of New South Wales UNSW Sydney 2052
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Addition Cancer fields
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